International Conference on Harmonisation

Electronic Standards for the Transfer of Regulatory Information (ESTRI)

Welcome to the International Conference on Harmonisation Multi-disciplinary Group 2 (ICH-M2) web site. Hosted by the U. S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER), this web site provides background information about the M2 expert working group, as well as documents resulting from its efforts to establish electronic standards for the transfer of pharmaceutical regulatory information. The Table of Contents to the left provides entry to this information. 

FDA hosts this Web site. Availability of documents on this Web site does not necessarily mean that they have been reviewed and approved by the FDA. For a list of FDA approved documents, please go to the relevant FDA Web page. 

For guidance documents: http://www.fda.gov/cder/guidance/index.htm; 

For information on international activities: http://www.fda.gov/cder/audiences/default.htm#International

Electronic Common Technical Document (eCTD) 

•  Step 2 eCTD

Click on the links below for the products of the working group.

Recommendations for secure messaging, physical media and EDI Gateway:

• Recommendations

Specifications for the electronic submission of  Individual Case Safety Reports (ICSR):

• M2 Specification Version 2.3   DTD Version 2.1

• M2 Specification Version 2.24 DTD Version 2.0

• DTD Version 1.0

Related sites:

International Conference on Harmonisation Site

Center for Drug Evaluation and Research Home Page

Main | Background | Objectives | Approach | Recommendations

Functionality | Meetings | Glossary| Future | Contacts

Last Updated: July 21, 2003